81_FR_13420 81 FR 13371 - Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes; Availability

81 FR 13371 - Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 49 (March 14, 2016)

Page Range13371-13372
FR Document2016-05622

The Food and Drug Administration (FDA, the Agency) is announcing the availability for public comment of the draft environmental assessment (EA) submitted by Oxitec Ltd. and a preliminary finding of no significant impact (FONSI) in support of the conduct of an investigational release of genetically engineered (GE) mosquitoes under an investigational new animal drug exemption.

Federal Register, Volume 81 Issue 49 (Monday, March 14, 2016) 
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13371-13372]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-2235]


Draft Environmental Assessment and Preliminary Finding of No 
Significant Impact Concerning Investigational Use of Oxitec OX513A 
Mosquitoes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency) is 
announcing the availability for public comment of the draft 
environmental assessment (EA) submitted by Oxitec Ltd. and a 
preliminary finding of no significant impact (FONSI) in support of the 
conduct of an investigational release of genetically engineered (GE) 
mosquitoes under an investigational new animal drug exemption.

DATES: Submit either electronic or written comments on the draft EA by 
April 13, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-2235 for Draft Environmental Assessment and Preliminary 
Finding of No Significant Impact Concerning Investigational Use of 
Oxitec OX513A Mosquitoes. Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. Persons with access to the Internet may 
obtain the draft EA at either http://www.fda.gov/animalveterinary/developmentapprovalprocess/environmentalassessments/ucm300656.htm or 
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Brinda Dass, Center for Veterinary 
Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8247, email: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing that a draft EA and 
preliminary FONSI, in support of a proposed investigational release 
(i.e., field trial) of OX513A Aedes aegypti GE mosquitoes (OX513A 
mosquitoes), as part of an existing mosquito control program in Key 
Haven, FL, are being made available for public comment. The OX513A is a 
strain of Ae. aegypti mosquito whose recombinant DNA (rDNA) construct 
encodes a conditional lethality trait such that the offspring of the 
matings of male OX513A mosquitoes and wild type Ae. aegypti do not 
survive to adulthood. The intended result is a decrease in the overall 
population of Ae. aegypti in the environment. Only male OX513A 
mosquitoes are intended to be released.
    To encourage public transparency, and in compliance with 21 CFR 
25.51(b)(3), the Agency is placing Oxitec Ltd.'s draft EA and 
preliminary FONSI that are the subject of this notice on public display 
at the Division of Dockets

[[Page 13372]]

Management (see DATES and ADDRESSES) for public review and comment for 
30 days. Oxitec Ltd. prepared the draft EA. The preliminary FONSI is 
based upon Oxitec Ltd.'s draft EA. FDA is considering the draft EA and 
tentatively agrees with its conclusion that conduct of this trial will 
result in no significant impacts on the environment. If nothing changes 
FDA's tentative determination, FDA will prepare and release its own 
revised, final EA and final FONSI. The Agency intends to take comments 
received under advisement in determining whether to prepare a revised, 
final EA and FONSI. If FDA does not agree with the preliminary 
conclusion that conduct of this trial will result in no significant 
impacts on the environment, it will prepare an environmental impact 
statement.

    Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05622 Filed 3-11-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices 13371 within 30 days of publication. Written information, or other information that information marked as ‘‘confidential’’ comments and recommendations for the identifies you in the body of your will not be disclosed except in proposed information collection should comments, that information will be accordance with 21 CFR 10.20 and other be sent directly to the following: Office posted on http://www.regulations.gov. applicable disclosure law. For more of Management and Budget, Paperwork • If you want to submit a comment information about FDA’s posting of Reduction Project, Email: OIRA_ with confidential information that you comments to public dockets, see 80 FR SUBMISSION@OMB.EOP.GOV, Attn: do not wish to be made available to the 56469, September 18, 2015, or access Desk Officer for the Administration for public, submit the comment as a the information at: http://www.fda.gov/ Children and Families. written/paper submission and in the regulatoryinformation/dockets/ manner detailed (see ‘‘Written/Paper default.htm. Robert Sargis, Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to ACF Certifying Officer. read background documents or the [FR Doc. 2016–05605 Filed 3–11–16; 8:45 am] Written/Paper Submissions electronic and written/paper comments BILLING CODE 4184–73–P Submit written/paper submissions as received, go to http:// follows: www.regulations.gov and insert the • Mail/Hand delivery/Courier (for docket number, found in brackets in the DEPARTMENT OF HEALTH AND written/paper submissions): Division of heading of this document, into the HUMAN SERVICES Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts and Drug Administration, 5630 Fishers and/or go to the Division of Dockets Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. • For written/paper comments [Docket No. FDA–2014–N–2235] 1061, Rockville, MD 20852. submitted to the Division of Dockets Submit written requests for single Draft Environmental Assessment and Management, FDA will post your copies of the guidance to the Policy and Preliminary Finding of No Significant comment, as well as any attachments, Regulations Staff (HFV–6), Center for Impact Concerning Investigational Use except for information submitted, Veterinary Medicine, Food and Drug of Oxitec OX513A Mosquitoes; marked and identified, as confidential, Administration, 7519 Standish Pl., Availability if submitted as detailed in Rockville, MD 20855. Send one self- ‘‘Instructions.’’ AGENCY: Food and Drug Administration, Instructions: All submissions received addressed adhesive label to assist that HHS. must include the Docket No. FDA– office in processing your requests. 2014–N–2235 for Draft Environmental Persons with access to the Internet may ACTION: Notice. Assessment and Preliminary Finding of obtain the draft EA at either http:// SUMMARY: The Food and Drug No Significant Impact Concerning www.fda.gov/animalveterinary/ Administration (FDA, the Agency) is Investigational Use of Oxitec OX513A developmentapprovalprocess/ announcing the availability for public Mosquitoes. Received comments will be environmentalassessments/ comment of the draft environmental placed in the docket and, except for ucm300656.htm or http:// assessment (EA) submitted by Oxitec those submitted as ‘‘Confidential www.regulations.gov. Ltd. and a preliminary finding of no Submissions,’’ publicly viewable at FOR FURTHER INFORMATION CONTACT: significant impact (FONSI) in support of http://www.regulations.gov or at the Brinda Dass, Center for Veterinary the conduct of an investigational release Division of Dockets Management Medicine (HFV–2), Food and Drug of genetically engineered (GE) between 9 a.m. and 4 p.m., Monday Administration, 7500 Standish Pl., mosquitoes under an investigational through Friday. Rockville, MD 20855, 240–276–8247, new animal drug exemption. • Confidential Submissions—To email: abig@fda.hhs.gov. DATES: Submit either electronic or submit a comment with confidential SUPPLEMENTARY INFORMATION: FDA is written comments on the draft EA by information that you do not wish to be announcing that a draft EA and April 13, 2016. made publicly available, submit your preliminary FONSI, in support of a ADDRESSES: You may submit comments comments only as a written/paper proposed investigational release (i.e., as follows: submission. You should submit two field trial) of OX513A Aedes aegypti GE copies total. One copy will include the mosquitoes (OX513A mosquitoes), as Electronic Submissions information you claim to be confidential part of an existing mosquito control Submit electronic comments in the with a heading or cover note that states program in Key Haven, FL, are being following way: ‘‘THIS DOCUMENT CONTAINS made available for public comment. The • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The OX513A is a strain of Ae. aegypti www.regulations.gov. Follow the Agency will review this copy, including mosquito whose recombinant DNA instructions for submitting comments. the claimed confidential information, in (rDNA) construct encodes a conditional Comments submitted electronically, its consideration of comments. The lethality trait such that the offspring of including attachments, to http:// second copy, which will have the the matings of male OX513A www.regulations.gov will be posted to claimed confidential information mosquitoes and wild type Ae. aegypti the docket unchanged. Because your redacted/blacked out, will be available do not survive to adulthood. The comment will be made public, you are for public viewing and posted on intended result is a decrease in the solely responsible for ensuring that your http://www.regulations.gov. Submit overall population of Ae. aegypti in the comment does not include any both copies to the Division of Dockets jstallworth on DSK7TPTVN1PROD with NOTICES environment. Only male OX513A confidential information that you or a Management. If you do not wish your mosquitoes are intended to be released. third party may not wish to be posted, name and contact information to be To encourage public transparency, such as medical information, your or made publicly available, you can and in compliance with 21 CFR anyone else’s Social Security number, or provide this information on the cover 25.51(b)(3), the Agency is placing Oxitec confidential business information, such sheet and not in the body of your Ltd.’s draft EA and preliminary FONSI as a manufacturing process. Please note comments and you must identify this that are the subject of this notice on that if you include your name, contact information as ‘‘confidential.’’ Any public display at the Division of Dockets VerDate Sep<11>2014 14:27 Mar 11, 2016 Jkt 238001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1

13372 Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices Management (see DATES and ADDRESSES) electronic or written comments assessments of the extended-release and for public review and comment for 30 regarding this meeting. Submit long-acting (ER/LA) Opioid Analgesics days. Oxitec Ltd. prepared the draft EA. electronic comments to http:// REMS. The Agency will seek the The preliminary FONSI is based upon www.regulations.gov. Submit written committees’ comments as to whether Oxitec Ltd.’s draft EA. FDA is comments to the Division of Dockets this REMS with ETASU assures safe considering the draft EA and tentatively Management (HFA–305), Food and Drug use, is not unduly burdensome to agrees with its conclusion that conduct Administration, 5630 Fishers Lane, rm. patient access to the drugs, and to the of this trial will result in no significant 1061, Rockville, MD 20852. All extent practicable, minimizes the impacts on the environment. If nothing comments received will be posted burden to the healthcare delivery changes FDA’s tentative determination, without change, including any personal system. FDA will prepare and release its own information provided. It is only The ER/LA Opioid Analgesics REMS revised, final EA and final FONSI. The necessary to send one set of comments. requires that prescriber training will be Agency intends to take comments Identify comments with the docket made available to healthcare providers received under advisement in number found in brackets in the who prescribe ER/LA opioid analgesics. determining whether to prepare a heading of this document. Received Training is considered ‘‘REMS- revised, final EA and FONSI. If FDA comments may be seen in the Division compliant’’ if: (1) It, for training does not agree with the preliminary of Dockets Management between 9 a.m. provided by continuing education conclusion that conduct of this trial will and 4 p.m., Monday through Friday. providers, is offered by an accredited result in no significant impacts on the Comments received on or before April provider to licensed prescribers, (2) it environment, it will prepare an 19, 2016, will be provided to the includes all elements of the FDA environmental impact statement. committees before the meeting. Blueprint for Prescriber Education for Location: FDA White Oak Campus, ER/LA Opioid Analgesics (Blueprint), Dated: March 8, 2016. 10903 New Hampshire Ave., Bldg. 31 (3) it includes a knowledge assessment Leslie Kux, Conference Center, the Great Room (Rm. of all the sections of the Blueprint, and Associate Commissioner for Policy. 1503), Silver Spring, MD 20993–0002. (4) it is subject to independent audit to [FR Doc. 2016–05622 Filed 3–11–16; 8:45 am] Answers to commonly asked questions confirm that conditions of the REMS BILLING CODE 4164–01–P including information regarding special training have been met. The Agency will accommodations due to a disability, seek the committees’ input on possible visitor parking, and transportation may modifications to the ER/LA Opioid DEPARTMENT OF HEALTH AND be accessed at: http://www.fda.gov/ Analgesics REMS, including expansion HUMAN SERVICES AdvisoryCommittees/ of the scope and content of prescriber AboutAdvisoryCommittees/ training and expansion of the REMS Food and Drug Administration ucm408555.htm. program to include immediate-release [Docket No. FDA–2016–N–0820] Contact Person: Stephanie L. opioids. Begansky, Center for Drug Evaluation Comments from the public can be Drug Safety and Risk Management and Research, Food and Drug submitted to the docket (see the Advisory Committee and the Administration, 10903 New Hampshire ADDRESSES section) on a broad Anesthetic and Analgesic Drug Ave., Bldg. 31, Rm. 2417, Silver Spring, evaluation of the ER/LA Opioid Products Advisory Committee; Notice MD 20993–0002, 301–796–9001, Fax: Analgesics REMS program and whether of Meeting 301–847–8533, email: AADPAC@ the ER/LA opioid analgesics REMS fda.hhs.gov, or FDA Advisory should be modified as well as any AGENCY: Food and Drug Administration, Committee Information Line, 1–800– proposed modifications. Comments may HHS. 741–8138 (301–443–0572 in the include but are not limited to: (1) ACTION: Notice. Washington, DC area). A notice in the Alternative methodologies for Federal Register about last minute evaluating the overall impact of the This notice announces a forthcoming modifications that impact a previously program on knowledge and behavior by meeting of a public advisory committee announced advisory committee meeting prescribers and patients, (2) the overall of the Food and Drug Administration cannot always be published quickly impact of the REMS on the adverse (FDA). The meeting will be open to the enough to provide timely notice. events it is intended to mitigate; (3) public. Therefore, you should always check the whether the FDA Blueprint or other Name of Committees: Drug Safety and Agency’s Web site at http:// tools (e.g., Medication Guide or Patient Risk Management Advisory Committee www.fda.gov/AdvisoryCommittees/ Counseling Document) should be and the Anesthetic and Analgesic Drug default.htm and scroll down to the revised and/or expanded; (4) the use of Products Advisory Committee. appropriate advisory committee meeting the continuing education as a General Function of the Committees: link, or call the advisory committee component of the REMS as a To provide advice and information line to learn about possible mechanism for providing prescriber recommendations to the Agency on modifications before coming to the training; (5) whether to expand the FDA’s regulatory issues. meeting. REMS program to include immediate- Date and Time: The meeting will be Agenda: The Food and Drug release opioids; and (6) how additional held on May 3, 2016, from 8 a.m. to 5 Administration Amendments Act of REMS tools or ETASU (e.g., required p.m. and May 4, 2016, from 8 a.m. to 5 2007 (Pub. L. 110–85) requires FDA to prescriber or pharmacist training, p.m. bring, at least annually, one or more jstallworth on DSK7TPTVN1PROD with NOTICES required patient agreements), if ADDRESSES: FDA is opening a docket for drugs with Risk Evaluation and recommended, may impact the public comment on this meeting. The Mitigation Strategies (REMS) with healthcare delivery system and patient docket number is FDA–2016–N–0820. Elements to Assure Safe Use (ETASU) access to ER/LA opioid analgesics. The docket will open for public before its Drug Safety and Risk FDA intends to make background comment on March 14, 2016. The Management Advisory Committee material available to the public no later docket will close on June 4, 2016. (DSaRM). On May 3 and 4, 2016, the than 2 business days before the meeting. Interested persons may submit either committees will discuss results from If FDA is unable to post the background VerDate Sep<11>2014 14:27 Mar 11, 2016 Jkt 238001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\14MRN1.SGM 14MRN1


Document Created: 2016-03-12 01:00:59
Document Modified: 2016-03-12 01:00:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the draft EA by April 13, 2016.
ContactBrinda Dass, Center for Veterinary Medicine (HFV-2), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8247, email: [email protected]
FR Citation81 FR 13371 
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